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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Alkermes PLC says ‍initiates rolling submission of ALKS 5461 NDA to U.S. FDA
Monday, 21 Aug 2017 07:00am EDT 

Aug 21 (Reuters) - Alkermes Plc : :Alkermes PLC- ‍Initiates rolling submission of ALKS 5461 NDA to U.S. FDA; Expects to complete submission of NDA for medicine by year-end 2017​.  Full Article

Alkermes qtrly gaap loss per share $0.28
Thursday, 27 Jul 2017 07:00am EDT 

July 27 (Reuters) - Alkermes Plc ::Alkermes Plc reports second quarter 2017 financial results.Qtrly gaap loss per share $0.28.Qtrly non-gaap earnings per share of $0.01.Qtrly revenues increased 12% year-over-year to $218.8 million.Alkermes Plc says reiterates its financial expectations for 2017.  Full Article

Alkermes announces positive preliminary topline results
Thursday, 29 Jun 2017 04:00pm EDT 

June 29 (Reuters) - Alkermes Plc ::Alkermes announces positive preliminary topline results from phase 3 antipsychotic efficacy study of ALKS 3831 for treatment of schizophrenia.Alkermes announces positive preliminary topline results from phase 3 antipsychotic efficacy study of ALKS 3831 for treatment of schizophrenia.Alkermes Plc - study met prespecified primary endpoint.Alkermes - ALKS 3831 demonstrating statistically significant reductions from baseline in positive and negative syndrome scale scores versus placebo.Alkermes Plc - study also met its key secondary endpoint.Alkermes Plc - study met prespecified primary endpoint, with ALKS 3831.Alkermes - enlighten-2, six-month phase 3 study evaluating weight gain profile of olanzapine compared to ALKS 3831, is ongoing with data expected in 2018.Alkermes Plc - ALKS 3831 demonstrated statistically significant reductions from baseline in positive and negative syndrome scale scores compared to placebo.  Full Article

Alkermes announces initiation of study 217 for ALKS 5461
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Alkermes Plc :Alkermes announces initiation of study 217 for ALKS 5461 for treatment of major depressive disorder.‍phase 3B study designed to further evaluate ALKS 5461's potential benefits on mood domains regulated by endogenous opioid modulation​.‍Company reiterates plans to submit new drug application to FDA by year-end 2017​.  Full Article

Alkermes says FDA approves two-month ARISTADA for treatment of schizophrenia
Tuesday, 6 Jun 2017 07:00am EDT 

June 6 (Reuters) - Alkermes plc ::FDA approves two-month ARISTADA® for treatment of schizophrenia.New two-month dose is expected to be available in mid-June.Says new two-month dose of ARISTADA is expected to be available in mid-June.  Full Article

Alkermes, certain subsidiaries enter into amendment to amended, restated credit agreement
Thursday, 13 Oct 2016 04:17pm EDT 

Alkermes Plc : Alkermes - On Oct. 12, co, certain other subsidiaries of company entered into an amendment to amended and restated credit agreement - SEC filing . Alkermes - Amendment amends credit agreement to extend maturity date of the about $286 million outstanding term loan by two years to September 25, 2021 Source: (http://bit.ly/2e5hN5b) Further company coverage: [ALKS.O] ((bangalore.newsroom@thomsonreuters.com;)).  Full Article

Alkermes submits supplemental new drug application to FDA
Monday, 8 Aug 2016 07:00am EDT 

Alkermes Plc : Alkermes submits supplemental new drug application to FDA for two month dosing option of Aristada® for treatment of schizophrenia . Notice of allowance issued for Aristada patent application, extending expected protection into 2035 .Expects patent to issue within next few months and expire no earlier than march 2035.  Full Article

Alkermes says U.S. District Court issued unambiguous opinion in favor of co, U.S. FDA - SEC filing
Friday, 29 Jul 2016 12:55pm EDT 

Alkermes Plc: On July 28 U.S. District Court for District of Columbia issued unambiguous opinion in favor of co and U.S. FDA - SEC filing . U.S. District Court unambiguous opinion affirming in all respects FDA's decision to approve Aristada for treatment of schizophrenia .U.S. District Court unambiguous opinion also "denying action filed by Otsuka for declaratory and injunctive relief".  Full Article

Alkermes PLC gives FY 2016 guidance
Thursday, 25 Feb 2016 07:01am EST 

Alkermes PLC:Expects FY 2016 total revenues to range from $700 million to $750 million.Expects FY 2016 GAAP net loss to be in range of $225 million to $255 million, or a basic and diluted loss per share of $1.48 to $1.68.Expects FY 2016 non-GAAP net loss to be in the range of $25 million to $55 million, and non-GAAP basic and diluted loss per share to be between $0.16 and $0.36.  Full Article

Alkermes PLC announces positive topline results from clinical study of Two-month dosing option of ARISTADA for treatment of Schizophrenia
Thursday, 25 Feb 2016 07:00am EST 

Alkermes PLC:Announces positive topline results from clinical study of Two-month dosing option of ARISTADA for treatment of Schizophrenia.Results showed 1064 mg dose of aristada achieved therapeutically relevant plasma concentrations of aripiprazole with pk profile.Says most common adverse events for the two-month dosing interval were injection site pain and dyskinesia.Plans to submit supplemental new drug application to the U.S. food and drug administration (FDA) in the second half of 2016.Says potential new offering would expand range of aristada doses to three interval options.  Full Article

BRIEF-Alkermes qtrly gaap loss per share $0.28

* Qtrly revenues increased 12% year-over-year to $218.8 million